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Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Arizona Oncology Associates, PC - HAL
Sedona, Arizona, 86336 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Ineligibility for participation in any ongoing clinical study of the investigational
product

- Age ≥18 years

- Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK
rearrangement or a ROS1 rearrangement

- For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If
prior ALK-TKI was crizotinib, additional prior treatment required with at least one
second generation ALK-TKI registered and commercially available. For patients with
resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance
mutation), prior treatment with an ALK/ROS1 inhibitor is not required.

- For ROS1 positive patients: failure to prior treatment with at least crizotinib

- Adequate bone marrow, liver, renal, pancreatic functions

- Negative pregnancy test at screening

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or
participation in other studies with investigational drugs within the timeframe
indicated in the protocol

- History of interstitial fibrosis or interstitial lung disease

- Concomitant use of prohibited medication

- Clinically significant cardiovascular disease: cerebral vascular accident/stroke,
myocardial infarction, unstable angina, congestive heart failure, second degree or
third degree atrioventricular block (unless paced) or any AV block with PR >220 msec

- Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with
QTc >470 msec, or congenital long QT syndrome

- History of or predisposing characteristics for acute pancreatitis

NCT03178071
Pfizer
Available
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

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Similar Trials

Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer Carrying an ALK or ROS1 Rearrangement
An Expanded Access Protocol For Lorlatinib For Treatment Of Patients With Advanced Non-small Cell Lung Cancer Harboring Specific Molecular Alterations
This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol B7461020 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted. This statement has been placed in the Detailed Description section of the protocol registration on ClinicalTrials.gov.
Expanded Access
Individual Patients
Non Small Cell Lung Cancer With ALK or ROS1 Rearrangement
Drug: Lorlatinib (PF-06463922)
oral tablets, administered daily, continuously
Not Provided
 
Available

Inclusion Criteria:

  • Ineligibility for participation in any ongoing clinical study of the investigational product
  • Age ?18 years
  • Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK rearrangement or a ROS1 rearrangement
  • Failure of all locally approved ALK/ROS1 inhibitors or at least one approved chemotherapy regimen or at least one approved immunotherapy agent
  • ECOG Performance Status 0, 1, or 2
  • Adequate bone marrow, liver, renal, pancreatic functions
  • negative pregnancy test at screening

Exclusion Criteria:

  • Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or participation in other studies with investigational drugs within the timeframe indicated in the protocol
  • History of interstitial fibrosis or interstitial lung disease
  • Concomitant use of prohibited medication
  • Clinically significant cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, second degree or third degree atrioventricular block (unless paced) or any AV block with PR >220 msec
  • Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with QTc >470 msec, or congenital long QT syndrome
  • History of or predisposing characteristics for acute pancreatitis
  • Symptomatic brain metastases
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03178071
B7461020
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

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